Online Mindfulness-based Program for Parents of Children With Autism

May 12, 2025 updated by: Megan Chang, San Jose State University

Use of a Telehealth Approach to Build Resilience in Parents of Children With Autism Through Mindfulness Practice

The goal of the project is to investigate the effects of online 8-week MBSR intervention on diverse parents to support their children with ASD. The investigators will conduct a randomized waitlist-controlled trial with a sample size 22 parents. This study utilizes psychological, behavioral and psychophysiological measures with parents of children with ASD ages 6-12. The first aim is to determine if parents of children with autism from diverse populations are willing participate in and complete an online MBSR program and if online delivery is as effective as in-person program. The battery of parental-report psychological assessments to measure resilience, parental sleep and stress as well as children's behaviors will be administered before and after the treatment. The second aim is to investigate the effects of a virtual MBSR intervention on cardiovascular and sympathetic nervous activity measured by continuous EDA and EKG. Participants will participate in a validated laboratory stress protocol consisting of mental arithmetic and speech tasks before and after the MBSR intervention.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

After the participants eligibility are confirmed, their signatures will be obtained on the consent form. Three data collection phases are included in this protocol: baseline, post 3 months and post 6 months. All tests are identical in which phase. Each test includes a survey packet and the lab experiment. The surveys packet includes: the Connor-Davidson Resilience Scale, Mindfulness Attention Awareness Scale, Parenting Stress Index - 4th edition Short Form, Pittsburgh Sleep Quality Index, Adult Sensory Processing Scale, Strength and Difficulties Questionnaire, and WHO Quality of Life-BREF. For the lab experiment, EKG and EDA data will be collected through lab protocol, which include a 5-min baseline recording followed by Trier Social Stress Test (speaking, math test) and then another 5-min rest period. After that, a pre-recorded 15-min mindfulness practice will be played for the participants to practice. After completing the baseline test, participants will be randomly grouped into the MBSR group or the waitlist controlled group. The online MBSR program is a 8-week group-based, intervention, which will be delivered by a UMASS trained MBSR instructor.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • California
      • San Jose, California, United States, 95192
        • San Jose State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • have a child aged 6-12 years old that has been diagnosed by a psychiatrist or a psychologist with autism spectrum disorder
  • English speaking
  • parents do not receive any form of psychological or behavioral treatment at the time of referral
  • parents have never participated in a MBSR workshop prior to the enrollment
  • parents do not have previous meditation experience
  • parents do not have a severe mental illness (self-assessed),
  • parents agree to participate in the 8-week MBSR intervention

Exclusion Criteria:

  • parents who currently receive psychotherapy or take medications for health issues

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Online MBSR 1
received modified online 8-week group-based MBSR intervention delivered by a UMASS trained MBSR instructor
Behavioral: Online Mindfulness Based Stress Reduction
Based on the UMASS curriculum developed by Dr. Jon Kabat-Zinn, it is an 8-week mindfulness stress reduction program. It is a skill-based psychoeducational program that meets 2 hours for 8 weeks to discuss stress, cognition and health. The weekly intervention includes didactic presentations, class dialogue and inquiry, formal (e.g., body scan, walking meditation) and informal (e.g., awareness of pleasant and unpleasant events, interpersonal communications, etc.) mindfulness practice.
Other Names:
  • MBSR
Active Comparator: Waitlist control
On a waiting list to receive the identical intervention as the treatment group after the active treatment group completes.
Behavioral: Online Mindfulness Based Stress Reduction
Based on the UMASS curriculum developed by Dr. Jon Kabat-Zinn, it is an 8-week mindfulness stress reduction program. It is a skill-based psychoeducational program that meets 2 hours for 8 weeks to discuss stress, cognition and health. The weekly intervention includes didactic presentations, class dialogue and inquiry, formal (e.g., body scan, walking meditation) and informal (e.g., awareness of pleasant and unpleasant events, interpersonal communications, etc.) mindfulness practice.
Other Names:
  • MBSR

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Connor-Davidson Resilience Scale from baseline to midpoint
Time Frame: from baseline to midpoint (approximately 3 months from baseline)
This standardized assessment is comprised of 25 items, which measures 7 aspects of resilience including: hardiness, coping, adaptability, self-efficacy, meaningfulness/purpose, optimism, and regulation of emotion and cognition. Each item is rated on a 5-point Likert scale. The total score ranges from zero to 100. Higher score indicate greater resilience. It has been shown to have the sensitivity to detect the treatment effects.
from baseline to midpoint (approximately 3 months from baseline)
Change in Connor-Davidson Resilience Scale from baseline to exit evaluation
Time Frame: from baseline to exit evaluation (approximately 6 months from baseline)
This standardized assessment is comprised of 25 items, which measures 7 aspects of resilience including: hardiness, coping, adaptability, self-efficacy, meaningfulness/purpose, optimism, and regulation of emotion and cognition. Each item is rated on a 5-point Likert scale. The total score ranges from zero to 100. Higher score indicate greater resilience. It has been shown to have the sensitivity to detect the treatment effects.
from baseline to exit evaluation (approximately 6 months from baseline)
Change in Connor-Davidson Resilience Scale from midpoint to exit evaluation
Time Frame: from midpoint to exit evaluation (approximately 3 months from baseline to 6 months from baseline)
This standardized assessment is comprised of 25 items, which measures 7 aspects of resilience including: hardiness, coping, adaptability, self-efficacy, meaningfulness/purpose, optimism, and regulation of emotion and cognition. Each item is rated on a 5-point Likert scale. The total score ranges from zero to 100. Higher score indicate greater resilience. It has been shown to have the sensitivity to detect the treatment effects.
from midpoint to exit evaluation (approximately 3 months from baseline to 6 months from baseline)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mindfulness Attention Awareness Scale
Time Frame: from baseline to midpoint (approximately 3 months from baseline)
This 15-item standardized assessment evaluates awareness of or attention to the present moment in daily life. Each item is rated on a 6-point Likert scale. The total score ranges from 15 to 90 and higher scores indicate a greater mindfulness state. Each It has moderate to strong correlations with other measures of mindfulness and has been used with families with children with ASD .
from baseline to midpoint (approximately 3 months from baseline)
Mindfulness Attention Awareness Scale
Time Frame: from baseline to exit evaluation (approximately 6 months from baseline)
This 15-item standardized assessment evaluates awareness of or attention to the present moment in daily life. Each item is rated on a 6-point Likert scale. The total score ranges from 15 to 90 and higher scores indicate a greater mindfulness state. Each It has moderate to strong correlations with other measures of mindfulness and has been used with families with children with ASD .
from baseline to exit evaluation (approximately 6 months from baseline)
Mindfulness Attention Awareness Scale
Time Frame: from midpoint to exit evaluation (approximately 3 months from baseline to 6 months from baseline)
This 15-item standardized assessment evaluates awareness of or attention to the present moment in daily life. Each item is rated on a 6-point Likert scale. The total score ranges from 15 to 90 and higher scores indicate a greater mindfulness state. Each It has moderate to strong correlations with other measures of mindfulness and has been used with families with children with ASD .
from midpoint to exit evaluation (approximately 3 months from baseline to 6 months from baseline)
Parenting Stress Index - 4th edition Short Form
Time Frame: from baseline to midpoint (approximately 3 months from baseline)
This index has 36 items assessing parenting-related stress that includes a Total Stress scale along with three subscales: Parental Distress, Parent-Child Dysfunctional Interaction and Difficult Child. Each item is rated on the agreement from 1= strongly agree to 5=strongly disagree. The higher scores indicate a greater perceived stress.
from baseline to midpoint (approximately 3 months from baseline)
Parenting Stress Index - 4th edition Short Form
Time Frame: from baseline to exit evaluation (approximately 6 months from baseline)
This index has 36 items assessing parenting-related stress that includes a Total Stress scale along with three subscales: Parental Distress, Parent-Child Dysfunctional Interaction and Difficult Child. Each item is rated on the agreement from 1= strongly agree to 5=strongly disagree. The higher scores indicate a greater perceived stress.
from baseline to exit evaluation (approximately 6 months from baseline)
Parenting Stress Index - 4th edition Short Form
Time Frame: from midpoint to exit evaluation (approximately 3 months from baseline to 6 months from baseline)
This index has 36 items assessing parenting-related stress that includes a Total Stress scale along with three subscales: Parental Distress, Parent-Child Dysfunctional Interaction and Difficult Child. Each item is rated on the agreement from 1= strongly agree to 5=strongly disagree. The higher scores indicate a greater perceived stress.
from midpoint to exit evaluation (approximately 3 months from baseline to 6 months from baseline)
Pittsburgh Sleep Quality Index (Buysse et al., 1989)
Time Frame: from baseline to midpoint (approximately 3 months from baseline)
This 19-item questionnaire measures sleep quality and quantity based on 7 components: subjective sleep quality, sleep latency, sleep duration, sleep disturbance, use of sleep medication, and daytime dysfunction and global score. The score ranges from 0 to 21 and the higher scores indicate more sleep problems
from baseline to midpoint (approximately 3 months from baseline)
Pittsburgh Sleep Quality Index (Buysse et al., 1989)
Time Frame: from baseline to exit evaluation (approximately 6 months from baseline)
This 19-item questionnaire measures sleep quality and quantity based on 7 components: subjective sleep quality, sleep latency, sleep duration, sleep disturbance, use of sleep medication, and daytime dysfunction and global score. The score ranges from 0 to 21 and the higher scores indicate more sleep problems
from baseline to exit evaluation (approximately 6 months from baseline)
Pittsburgh Sleep Quality Index (Buysse et al., 1989)
Time Frame: from midpoint to exit evaluation (approximately 3 months from baseline to 6 months from baseline)
This 19-item questionnaire measures sleep quality and quantity based on 7 components: subjective sleep quality, sleep latency, sleep duration, sleep disturbance, use of sleep medication, and daytime dysfunction and global score. The score ranges from 0 to 21 and the higher scores indicate more sleep problems
from midpoint to exit evaluation (approximately 3 months from baseline to 6 months from baseline)
World Health Organization Quality of Life- BREF
Time Frame: from baseline to midpoint (approximately 3 months from baseline)
This 26-item standardized questionnaire assess quality of life. It is composed of 4 domains: physical health, psychological health, social relationships, and environmental. facets. Each item is rated on a 5-point response scale and the scores are transformed linearly to a 0-100 scale. The higher score indicates higher quality of life.
from baseline to midpoint (approximately 3 months from baseline)
World Health Organization Quality of Life- BREF
Time Frame: from baseline to exit evaluation (approximately 6 months from baseline)
This 26-item standardized questionnaire assess quality of life. It is composed of 4 domains: physical health, psychological health, social relationships, and environmental. facets. Each item is rated on a 5-point response scale and the scores are transformed linearly to a 0-100 scale. The higher score indicates higher quality of life.
from baseline to exit evaluation (approximately 6 months from baseline)
World Health Organization Quality of Life- BREF
Time Frame: from midpoint to exit evaluation (approximately 3 months from baseline to 6 months from baseline)
This 26-item standardized questionnaire assess quality of life. It is composed of 4 domains: physical health, psychological health, social relationships, and environmental. facets. Each item is rated on a 5-point response scale and the scores are transformed linearly to a 0-100 scale. The higher score indicates higher quality of life.
from midpoint to exit evaluation (approximately 3 months from baseline to 6 months from baseline)
Electrodermal activity (EDA)
Time Frame: from baseline to midpoint (approximately 3 months from baseline)
EDA is also known as skin conductance. Two electrodes are attached to the palm to record skin conductance level that measures sweat gland activity with a sampling rate of 1000 Hz through a lab protocol. The unit of EDA is denoted as uS or microsiemens.
from baseline to midpoint (approximately 3 months from baseline)
Electrodermal activity (EDA)
Time Frame: from baseline to exit evaluation (approximately 6 months from baseline)
EDA is also known as skin conductance. Two electrodes are attached to the palm to record skin conductance level that measures sweat gland activity with a sampling rate of 1000 Hz through a lab protocol. The unit of EDA is denoted as uS or microsiemens.
from baseline to exit evaluation (approximately 6 months from baseline)
Electrodermal activity (EDA)
Time Frame: from midpoint to exit evaluation (approximately 3 months from baseline to 6 months from baseline)
EDA is also known as skin conductance. Two electrodes are attached to the palm to record skin conductance level that measures sweat gland activity with a sampling rate of 1000 Hz through a lab protocol. The unit of EDA is denoted as uS or microsiemens.
from midpoint to exit evaluation (approximately 3 months from baseline to 6 months from baseline)
heart rate
Time Frame: from baseline to midpoint (approximately 3 months from baseline)
continuous data recording of electrocardiogram through a lab protocol. The recording data will be processed to generate analytical data showing average heart rate per 5 minutes.
from baseline to midpoint (approximately 3 months from baseline)
heart rate
Time Frame: from baseline to exit evaluation (approximately 6 months from baseline)
continuous data recording of electrocardiogram through a lab protocol. The recording data will be processed to generate analytical data showing average heart rate per 5 minutes.
from baseline to exit evaluation (approximately 6 months from baseline)
heart rate
Time Frame: from midpoint to exit evaluation (approximately 3 months from baseline to 6 months from baseline)
continuous data recording of electrocardiogram through a lab protocol. The recording data will be processed to generate analytical data showing average heart rate per 5 minutes.
from midpoint to exit evaluation (approximately 3 months from baseline to 6 months from baseline)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
San Jose State University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Megan Chang, PhD, San Jose State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 15, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 30, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 2, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 18, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 22, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 15, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 22124

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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